Sponsor File Index

Study Title
CI/PI Name
Sponsor R&D Number
Section / Contents / On file
( or n/a) / Details
1 / Contact Information
1.1 / Contact details sheet
2 / Protocol
2.1 / Current approved protocol (signed and dated)
2.2 / Previous approved protocol versions (signed and dated)
3 / Other study documents
3.1 / Current approved patient information sheet
3.2 / Previous approved patient information sheet
3.3 / Current approved informed consent form
3.4 / Previous approved informed consent form
3.5 / Current approved GP letter
3.6 / Previous approved GP letter
3.7 / Current approved participant invitation letter
3.8 / Previous approved participant invitation letter
3.9 / Current approved advertisements
3.10 / Previous approved advertisements
3.11 / Other approved study documents (current)
3.12 / Other approved study documents (previous)
3.13 / Amendment log
4 / Sponsor Approvals
4.1 / Risk assessment
4.2 / Sponsorship letter
4.3 / Sponsorship committee correspondence
4.4 / Insurance letter
4.5 / Sponsor approval letter to apply for a CTA
4.6 / Sponsor notification of amendments
4.7 / Correspondence
5 / Ethics
5.1 / Initial ethics submission and favourable opinion letter
5.2 / Submission and favourable opinion of amendments
6 / MHRA
6.1 / CTA submission and notice of acceptance letter
6.2 / Submission and approval of amendments
7 / R&D Management Approval
7.1 / IRAS R&D form, SSI and R&D Management approval letter
7.2 / NHS costings
7.3 / Project Registration Form
7.4 / Certificateof compliance
7.5 / Amendment submission letters and R&D amendment approval letters
7.6 / Correspondence
8 / Other Approvals (e.g. GTAC, MHRA device studies, ARSAC, etc)
8.1 / Other regulatory approval application(s) and approval(s)
8.2 / Submission and approval of amendments
9 / Agreements and Funding
9.1 / Grant application and award letter
9.2 / Study agreements
9.3 / Agreement log
10 / Study Staff
10.1 / CI/PI CV
10.2 / CVs of other trial personnel
10.3 / GCP certificates
10.4 / Signature and delegation of responsibilities log
11 / Data Management
11.1 / Blank CRF
11.2 / Data management plan (if not in protocol)
11.3 / Statistical analysis plan (if not in protocol)
12 / Safety Reporting
12.1 / SAE forms
12.2 / SUSARs
12.3 / Pregnancy forms
12.4 / Details of any urgent safety measures
12.5 / Notifications to Investigators of safety information
13 / IMP
13.1 / Current IB/SmPC
13.2 / Previous versions of IB/SmPC
13.3 / Sample of IMP label
13.4 / IMP management plan
14 / Labs
14.1 / NHS Lab letter and certificate of accreditation
14.2 / NHS Lab reference ranges
14.3 / UoD Labs analytical plan
15 / Monitoring
15.1 / Monitoring plan
15.2 / Monitoring visit log
15.3 / Monitoring visit reports
16 / Protocol Deviations and Breaches
16.1 / Deviations and breach log
16.2 / Other Breach documentation
17 / Reporting
17.1 / REC Annual progress report
17.2 / DSUR
17.3 / Other reports
18 / End of Study
18.1 / End of trial declaration
18.2 / End of study report
19 / Correspondence

Doc ref: 096 Sponsor file index Version 6.0

06/01/2014Page 1 of 3